MRI Outcomes of VersaWrap Nerve Protector Following Surgery
Enrolling by invitation
Conditions studied: Lumbar Decompression
In brief
The purpose of this study is to evaluate enhancement patterns in magnetic resonance imaging (MRI) evidence following the use of VersaWrap in bilateral lumbar decompression surgeries.
Key facts
- Study ID
- NCT06942819
- Run by
- Research Source
- People needed
- 26
- Starts
- 2025-08-08
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2025-08-22
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patients aged ≥18 and ≤65 at time of surgery
- Patients undergoing lumbar decompression bilaterally at one level from L4-S1
- Psychologically, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule, study requirements with a signed informed consent.
You may not qualify if…
- Non-English speaking
- Known allergy or sensitivity to citrate, alginate or hyaluronate
- Known allergy or sensitivity to MRI contrast dye
- Known to experience claustrophobia
- Pregnant or breastfeeding at time of surgery
- Incarcerated at time of surgery
- Prior lumbar surgery at the index level
- Conjunction device use at index level (i.e., Barricade)*
- Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol *Note: conjunction medications (i.e., Depo-Medrol, Marcaine/Epinephrine) are acceptable
Where it is running
- Austin Neurosurgeons — Austin, Texas, United States
Full record on ClinicalTrials.gov
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